Benralizumab achieves real-world reductions in severe asthma exacerbations, medical costs

Patients with severe asthma saw significant reductions in exacerbations, oral corticosteroid use, exacerbation-related health care resource utilization and medical costs with benralizumab, according to recent research.

Published in Annals of Allergy, Asthma & Immunology, the study is the first to assess the real-world impact of benralizumab (Fasenra, AstraZeneca), a monoclonal antibody that targets the alpha receptor of IL-5, the researchers said.

“Since the approval of benralizumab in the U.S., there has been limited real-world evidence available regarding its clinical benefit and its economic impact,” Fan Mu, PhD, vice president of Analysis Group, told Healio.

Fan Mu

“To the best of our knowledge, this study is the first to assess the clinical and economic impacts of benralizumab among treated patients in the U.S. with at least two asthma exacerbations, which fills an important data gap in the current body of literature and offers treatment insights to health care providers,” Mu said.

The primary cohort

The study’s primary cohort included 204 patients with asthma (mean age, 45.3 years; 68.6% female) aged 12 years and older with two or more records of benralizumab (mean prescriptions, 5.5) and two or more exacerbation episodes with no history of other biologic use in the previous 12 months.

Across the inpatient, ED and outpatient settings, this cohort saw exacerbation rates fall from 3.25 per person-year (PPY) in the pre-index period to 1.47 PPY in the post-index period (P < .001), representing a 55% reduction in exacerbation episodes.

Specifically, reduction rates included 48% among inpatient cases, 53% in ED cases and 59% in outpatient cases (P < .001), and 41.2% of patients had no exacerbation episodes during the post-index period at all.

In the 12 months before initiating benralizumab, 82.4% of patients in this cohort were dependent on oral corticosteroid (OCS) use, and that significantly dropped to 50% (P < .001) in the post-index period. Median cumulative OCS dosage dropped from 1,398 mg to 630 mg (P < .001) as well.

This cohort additionally experienced reductions in health care resource utilization (HCRU) of 42% for inpatient hospitalization, 46% for ED use and 57% for outpatient settings (P < .001 for all). Between the pre-index and post-index periods, the mean cumulative number of inpatient days related to asthma exacerbation fell from 2.78 to 1.65 (P < .001).

The total medical costs of HCRU related to exacerbations fell 47% from $13,559 to $7,120, with inpatient stays dropping 42% from $6,888 to $3,990, ED visits declining 46% from $2,620 to $1,403 and outpatient visits falling 57% from $4,050 to $1,727 (P < .001 for all).

The secondary cohort

A secondary cohort included patients with asthma aged 12 years or older who had persistent benralizumab use of six or more records (n = 103), or who had switched from omalizumab (Xolair; Genentech, Novartis; n = 114) or mepolizumab (Nucala, GlaxoSmithKline; n = 90) to benralizumab. Patients across all groups had a mean age range of 48.3 to 51 years and a mean of 5.3 to 7.4 benralizumab prescriptions, and most patients were female (58.8%-69.1%).

The subgroups in the secondary cohort all experienced significant reductions in exacerbations with benralizumab, with rates falling by 62% (3.23 PPY vs. 1.23 PPY; P < .001) among persistent users, 54% (1.71 PPY vs. 0.79 PPY; P < .005) among omalizumab switchers and 34% (1.56 PPY vs. 1.02 PPY; P < .005) among mepolizumab switchers.

The median cumulative OCS dosage dropped from 1,530 mg to 565 mg (P < .001) for persistent users, from 1,143 mg to 610 mg for omalizumab switchers (P < .01) and from 1,400 mg to 645 mg (P < .01) for mepolizumab switchers.

Plus, the percentage of OCS-dependent patients across the secondary cohort fell from a range of 61.4% to 85.5% in the pre-index period to 44.7% to 56.6% in the post-index period (P < .01).

Patients in this cohort saw decreases in HCRU as well. Rates of exacerbation-related ED visits fell from 1.08 PPY to 0.4 PPY while rates of outpatient visits fell from 2.58 PPY to 1.02 PPY for persistent benralizumab users (P < .001 for both). Rates of outpatient visits fell from 1.36 PPY to 0.46 PPY for omalizumab switchers and from 1.12 PPY to 0.74 PPY for mepolizumab switchers (P < .05 for both).

Finally, exacerbation-related HRCU costs fell 50% from $12,098 to $6,042 (P < .001) for persistent benralizumab users, 49% from $6,827 to $3,502 (P < .001) for omalizumab switchers and 41% from $6,025 to $3,566 (P = .05) for mepolizumab switchers.

Looking forward

“This study found that, across all cohorts evaluated, patients treated with benralizumab experienced significant reductions in asthma exacerbations, less use of OCS and lower exacerbation-related health care utilization and medical costs,” Mu said.

In addition to these cost reductions, the researchers said that decreases in asthma exacerbations could lead to improvements in quality of life for these patients and even save lives. Further research in this area, they continued, would provide a more holistic view of the impact of benralizumab on patients with severe asthma.

Also, the researchers noted the potential benefits of the reduced need for OCS, which have been associated with obesity, type 2 diabetes and other adverse events among patients with severe asthma.

Next, Mu said, the researchers will work to further validate and expand these findings using different data sources and study populations so they could offer additional treatment insights to health care providers.

For more information:

Fan Mu, PhD, can be reached at fan.mu@analysisgroup.com.